- conducting hazard analyses for imported food
- evaluating the food and the foreign supplier
- determining and performing supplier verification activities
- taking corrective actions (when necessary)
- ensuring importer identification at entry
- maintaining records
The United States and certain countries have entered into Food Safety Systems Recognition Arrangements (SRA).
Therefore, importers of certain foods from foreign suppliers located in those countries who are in good compliance standing with those authorities, are not required to comply with standard FSVP requirements.
Currently, Canada, Australia and New Zealand, are the only countries that have signed SRA with the FDA, for the purpose of Foreign Supplier Verification Program (FSVP).
When the food is not intended for further manufacturing or processing and the importer chooses to follow the modified requirements, the importer must document that the foreign supplier is in, and under the regulatory oversight of the recognized foreign food safety system, and must determine and document whether the foreign supplier of the food is in good compliance standing with the food safety authority.
- Annual sales of less than $500,000 with at least half the sales to consumers or to local retailers or restaurants
- Averaging less than $1,000,000 in both sales plus the market value of food that is manufactured, processed, packed, or held without sale (e.g., held for a fee)
- Per year during the 3-year period preceding the current calendar year
If your company meets the eligibility requirements for a very small importer or an importer who is importing food from certain small foreign suppliers, written hazard analysis and evaluation of supplier’s performance, are not required.
You must document your eligibility for VSI status before initially importing food and thereafter on an annual basis by December 31 of each calendar year. You must document the supplier’s eligibility for small foreign supplier status before initially importing food and thereafter on an annual basis by December 31 of each calendar year.
• Use of qualified individual to conduct FSVP activities
• Hazard analysis
• Food and supplier evaluation
• Foreign supplier verification
• Corrective actions
Be ready to provide:
- DUNS Numbers (Manufacturer, Exporter, U.S. Importer)
- FDA Registration Numbers (Manufacturer, Exporter, U.S. Importer)
- Labels to verify FDA Compliance
- Certificates of Analysis, which must be issued by FDA Registered and Accredited Labs
- Hazard Analysis Critical Control Point (HACCP) plans, Global Food Safety Initiative (GFSI) schemes, or
other food defense and food safety programs to verify the safety of food being imported into the United States
- Letter of Assurance from manufacturers, suppliers, and foreign authorities
Because the appearance of the importer’s FSVP violations causes the food to be subject to Detention without Physical Examination (DWPE) under an Import Alert (a.k.a. Red List), the foreign supplier is not responsible for demonstrating that the conditions that gave rise to the appearance of the violations have been resolved. Nevertheless, it is possible that foreign suppliers may contact FDA offices seeking information about removal from the Red List. If this occurs, the FDA offices would direct the foreign suppliers to contact the relevant importers.